Status:
RECRUITING
Phase III Study Evaluating Induction Chemotherapy Followed by Chemoradiotherapy Compared to Standard Chemoradiotherapy for Locally Advanced SCCA
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Collaborating Sponsors:
Fondation ARCAD
Conditions:
Anal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Squamous cell carcinoma of the anus is still a rare disease but its incidence increases mostly due to its association with human papillomavirus (HPV). When localized, the standard treatment combines r...
Eligibility Criteria
Inclusion
- Anal Squamous cell carcinoma histologically proven
- Locally advanced tumors without metastases
- Stage T3 or T4
- Stage N1 (a, b or c) - any T (T1 to T4)
- Age ≥18 and ≤ 75 or \> 75 in case of score G8 \> 14 or favourable oncogeriatric assessment
- Measurable tumor on MRI
- Able to receive chemotherapy and radiotherapy
- No major comorbidity that may preclude the delivery of treatment
- Adequate hematologic function: absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 100 000/mm3, Hb ≥ 9g/dl
- Adequate renal function: creatinine clearance (according to MDRD formula) ≥ 60 ml/min
- Adequate hepatic function: AST and ALT ≤ 2.5 × Upper Limit of Normal and total bilirubin ≤ 1.5 × ULN
- WHO performance status \< 2
- Signature of informed consent
- A negative pregnancy test for inclusion in the study for all female patients of child-bearing potential. In case of a "urine pregnancy test", it must be a highly sensitive urine pregnancy test, in accordance with the recommendations of the CTFG regarding pregnancy risk management (Recommendations related to contraception and pregnancy testing in clinical trials)
- Female patients postmenopausal for at least one year or surgically infertile for at least 6 weeks, or effective contraception for male (until 6 months after the end of the investigational treatments) and female patients of childbearing potential (until 7.5 months after the end of treatment with cisplatine)
- Patient to be covered by a regimen of French Social Security system.
Exclusion
- Presence of metastases
- Stage T1N0 or T2N0
- History of pelvic radiotherapy
- Complete or partial Dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- Positive HIV serology with CD4 \< 400 / mm3
- Presence of neuropathy \> grade 2 according to NCIC-CTC 4.0
- Contraindication for chemotherapy and/or radiotherapy
- Concomitant treatment with CYP3A4 inhibitors or inducers
- Symptomatic cardiac or coronary insufficiency
- Progressive active infection or any unbalanced progressive severe condition in the last 6 months
- No contraindication to MRI imaging
- Other cancer treated within the last 3 years except in situ cervical carcinoma or basocellular/ spinocellular carcinoma or any other carcinoma in situ considered as cured
- breastfeeding woman.
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
- Live attenuated vaccines within 4 weeks before randomization 17. In case of hearing problem 18. In case of combination with phenytoin with prophylactic aim 19. In case of recent or concomitant treatment brivudine
Key Trial Info
Start Date :
February 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06207981
Start Date
February 26 2024
End Date
February 1 2030
Last Update
September 2 2025
Active Locations (114)
Enter a location and click search to find clinical trials sorted by distance.
1
AGEN-Cromg
Agen, France
2
Clinique Calabet
Agen, France
3
AIX EN PROVENCE CH Pays d'Aix
Aix-en-Provence, France
4
Amiens - Clinique de L'Europe
Amiens, France